AcelRx Pharmaceuticals Announces Data Presentations for Zalviso™ at US and International Medical Meetings

AcelRx Pharmaceuticals Announces Data Presentations for Zalviso™ at US and
International Medical Meetings
First medical meeting data presentations from Phase 3 clinical trial conducted
in orthopedic surgery patients
PR Newswire
REDWOOD CITY, Calif., Oct. 15, 2013
REDWOOD CITY, Calif., Oct. 15, 2013 /PRNewswire/ --AcelRx Pharmaceuticals,
Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced presentations of its previously
reported Phase 3 data for Zalviso™ (sufentanil sublingual microtablet system)
at several major medical meetings in Europe and the United States. Scheduled
for presentation during the European Federation of IASP Chapters (EFIC) Annual
Congress held in Florence, Italy on October 9-12, 2013 and at the American
Society of Anesthesiologists (ASA) meeting in San Francisco being held on
October 12-16, 2013, this is the first time data from the Phase 3 study of
Zalviso in the treatment of post-operative pain in patients after knee or hip
replacement surgery will be presented at a major medical meeting. In
addition, data from other Phase 3 Zalviso clinical studies will also be
presented at these medical meetings. Zalviso is a patient-activated,
non-invasive analgesic system, which delivers 15 mcg sufentanil per dose
sublingually as needed for pain control, subject to a 20-minute lockout period
between doses.
"Presentations at important medical meetings in both the EU and US of
favorable Phase 3 data for Zalviso represent an opportunity for investigators
to discuss the trials and their impressions of Zalviso with other thought
leaders in the pain-treatment community," stated Richard King, president and
CEO of AcelRx. "Presentations of this data are an important step in the
familiarization of the medical community with Zalviso, and in enabling early
understanding of the potential value the product may provide to their
patients, if approved by the regulatory agencies."
The Phase 3 orthopedic study data presented at these meetings were from a
trial that enrolled 426 patients to evaluate the ability of Zalviso to control
pain during the 48-hours immediately following knee or hip replacement
surgery, using the FDA-requested primary endpoint of Summed Pain Intensity
Difference to baseline (SPID-48), compared to a placebo-treated group of
patients. Results demonstrated that patients receiving Zalviso realized a
significantly greater SPID-48 during the study period than placebo-treated
patients (+76.1 vs. -11.5, p<0.001). Secondary endpoint datashowed that SPID
at 24 hours and 72 hours was also significantly greater in the
sufentanil-treated patients than in the placebo-treated patients (p<0.001 in
each case).Adverse events reported in the study were generally mild or
moderate in nature and were similar in both placebo and treatment groups for
the majority of adverse events.
In addition to data from this Phase 3 orthopedic study, three other posters
presented at both the EFIC meeting in Florence, Italy and the ASA in San
Francisco highlight results from a Phase 3 placebo-controlled study conducted
in abdominal surgery patients, a Phase 3 active-comparator study comparing
Zalviso to intravenous patient-controlled analgesia (IV PCA) with morphine,
and pharmacokinetic data from a study describing different routes of
sufentanil delivery (IV vs. transmucosal vs. oral/swallowed), highlighting the
clinical relevance of context-sensitive half-time (CST[½]) and plasma:central
nervous system equilibration half-life (t[½ke0]) in selecting the appropriate
opioid for treatment of acute pain.
Previously Reported Phase 3 Clinical Trial Results for Zalviso
At the end of September 2013, AcelRx submitted its NDA for Zalviso to the FDA
for the management of moderate-to-severe acute pain in adult patients in the
hospital setting. The filing is based the data from AcelRx's three Phase 3
clinical trials.Zalviso met the FDA-agreed primary endpoint in the two
double-blind, placebo-controlled Phase 3 registration studies conducted in
patients who had undergone major open-abdominal surgery or orthopedic surgery
that involved either knee or hip replacement procedures. In each of these
trials, patients treated with Zalviso to manage their post-surgical pain
reported a rapid onset of pain relief. In addition, patients treated with
Zalviso reported a greater SPID-48 compared to placebo-treated patients
(p=0.001 and p<0.001, respectively). Adverse events reported across these two
studies and considered possibly or probably related to treatment were
generally mild-to-moderate in nature and similar for the majority of adverse
events between Zalviso- and placebo-treated patients, with the exception of
itching, which was significantly greater (p < 0.05) in the Zalviso-treated
group.
The third Phase 3 study, an open-label, active-comparator trial comparing
Zalviso to IV PCA with morphine demonstrated that Zalviso was non-inferior
(p<0.001) and superior (p=0.007) to IV PCA morphine based on the primary
endpoint of Patient Global Assessment of method of pain control comparison
over the 48-hour trial period (PGA48) as determined by the combined percentage
of patients with PGA ratings of "good" or "excellent". Secondary endpoints of
summed pain intensity, summed pain relief, and dropouts due to inadequate
analgesia over the 48-hour study period were similar between treatment
groups. Zalviso-treated patients reported a significantly faster reduction in
pain intensity compared to IV PCA morphine-treated patients in the first 4
hours of treatment. Fewer patients experienced oxygen desaturation events
below 95% in the Zalviso-treated group compared to the IV PCA morphine-treated
patients (p=0.028). In addition, both nurses and patients rated Zalviso
significantly higher for Overall Satisfaction and Ease of Care compared to IV
PCA with morphine. Overall, adverse events in the comparison trial were
similar and most were mild-to-moderate in nature in both treatment groups.
About Zalviso
Zalviso is an investigational pre-programmed, non-invasive, handheld system
that allows hospital patients with moderate-to-severe acute pain to self-dose
with sublingual sufentanil microtablets to manage their pain. Zalviso is
designed to address the limitations of IV PCA by offering:
oA high therapeutic index opioid - Zalviso uses the high therapeutic index,
highly lipophilic opioid sufentanil, enabling delivery via a
non-intravenous route, and also supporting fast onset of effect.
oA non-invasive route of delivery - The sublingual route of delivery used
by Zalviso eliminates the risk of IV-related analgesic gaps and IV
complications, such as catheter-related infections in IV PCA treated
patients. In addition, because Zalviso patients do not require direct
connection to an IV PCA infusion pump through IV tubing, Zalviso allows
for ease of patient mobility.
oA simple, pre-programmed PCA solution – Zalviso is a pre-programmed PCA
system designed to eliminate the risk of infusion pump programming errors.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on
the development and commercialization of innovative therapies for the
treatment of acute and breakthrough pain. AcelRx's lead product candidate,
Zalviso, is designed to solve the problems associated with post-operative
intravenous patient-controlled analgesia which has been shown to cause harm to
patients following surgery because of the side effects of morphine, the
invasive IV route of delivery and the complexity of infusion pumps. AcelRx
has announced positive results from each of the three Phase 3 clinical trials
for Zalviso and has submitted an NDA to the FDA seeking its approval. AcelRx
has also announced positive top-line results for a Phase 2 trial for ARX-04, a
sufentanil formulation for the treatment of moderate-to-severe acute pain,
funded through a grant from the U.S. Army Medical Research and Materiel
Command. The company has two additional pain treatment product candidates,
ARX-02 and ARX-03, which have completed Phase 2 clinical development. For
additional information about AcelRx's clinical programs, please visit
www.acelrx.com.
Forward Looking Statements
This press release contains forward-looking statements, including, but not
limited to, statements related to the Phase 3 clinical trial data for Zalviso,
the therapeutic benefits of Zalviso, the process and timing of anticipated
future clinical development of AcelRx Pharmaceuticals' product candidates, the
commercial potential of Zalviso and the anticipated timing and therapeutic and
commercial potential of AcelRx Pharmaceuticals' other product candidates.
These forward-looking statements are based on AcelRx Pharmaceuticals' current
expectations and inherently involve significant risks and uncertainties.
AcelRx Pharmaceuticals' actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without limitation,
risks related to: the fact that FDA may not accept for filing Zalviso NDA;
ability to obtain regulatory approval for Zalviso, including whether the
results of the Phase 3 clinical trials for Zalviso are sufficient to obtain
marketing approval for Zalviso, which depends on the ability of AcelRx to
demonstrate to the satisfaction of the FDA the safety and efficacy of Zalviso
based upon its findings of the Phase 3 trials; any delays or inability to
obtain and maintain regulatory approval of its product candidates in the
United States and Europe; its ability to attract funding from partners or
collaborators with development, regulatory and commercialization expertise;
its ability to obtain sufficient financing to complete registration of its
product candidates in the United States and Europe; the market potential for
its product candidates; the accuracy of AcelRx Pharmaceuticals' estimates
regarding expenses, capital requirements and needs for financing; and other
risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals'
U.S. Securities and Exchange Commission filings and reports, including its
Quarterly Report on Form 10-Q filed with the SEC on August 12, 2013. AcelRx
Pharmaceuticals undertakes no duty or obligation to update any forward-looking
statements contained in this release as a result of new information, future
events or changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.
Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, 650.216.3511, jwelch@acelrx.com